Loading...

culinary health fund denosumab Coverage Update | OpenPayer

Modifiedculinary health fundPolicy N/A

Bone Modifiers - Denosumab Products (Prolia)

This policy governs prior authorization and medical benefit coverage criteria for denosumab subcutaneous injection products (Prolia and listed biosimilars) for treatment of bone loss and osteoporosis-related indications for Culinary Health Fund members and providers.

Policy Summary

Payerculinary health fund

PolicyBone Modifiers - Denosumab Products (Prolia)

Policy CodePolicy N/A

Change TypeSelected revision with biosimilars added and criteria consolidated

Effective DateN/A

Next Review DateOct 8, 2025

Key ActionSubmit prior authorization with clinical documentation showing the patient meets the specific indication criteria and evidence of prior bisphosphonate trial or intolerance as applicable.

SourceLink

POLICY UPDATE CHANGES

Policy name changed from 'Bone Modifiers - Prolia' to 'Bone Modifiers - Denosumab Products (Prolia)'.

Multiple biosimilar products (Jubbonti, Stoboclo, Conexxence, Bildyos, Ospomyv, Enoby, Bosaya) were added with the same criteria as Prolia.

Exceptions for prior bisphosphonate trial (e.g., osteoporotic or fragility fracture while on oral bisphosphonate) were removed and incorporated into a Note as examples of inadequate efficacy or significant intolerance.

Requirement added that patients be evaluated for chronic kidney disease mineral and bone disorder to reduce risk of denosumab-induced hypocalcemia.

New indications/conditions added in 'Other Uses with Supportive Evidence' including treatment of bone loss in prostate cancer patients receiving androgen deprivation therapy and increasing BMD in patients with breast cancer.

Condition 'Concurrent Use with Other Denosumab Products' was added to Conditions Not Recommended for Approval.

60 mgstandard dose

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

inv-01: FDA‑Approved Indication criteria

Covered when ALL specified conditions for each indication are met as described below

Breast cancer - bone loss (adjuvant aromatase inhibitor): Approve for 1 year if BOTH A and B are met: A) patient has breast cancer that is not metastatic to bone; AND B) patient is receiving aromatase inhibitor therapy (examples: anastrozole, letrozole, exemestane).

Dosing: 60 mg subcutaneously once every 6 months.

Prostate cancer - bone loss (androgen deprivation therapy): Approve for 1 year if BOTH A and B are met: A) patient has prostate cancer that is not metastatic to bone; AND B) patient meets ONE of: i) is receiving androgen deprivation therapy (examples include leuprolide formulations, degarelix, relugolix, triptorelin, goserelin); OR ii) has undergone bilateral orchiectomy.

Dosing: 60 mg subcutaneously once every 6 months.

Glucocorticoid‑Induced Osteoporosis (treatment): Approve for 1 year if BOTH A and B are met: A) patient is initiating or continuing systemic glucocorticoids; AND B) patient meets ONE of: i) tried zoledronic acid IV infusion; OR ii) tried ≥1 oral bisphosphonate and (a) inadequate efficacy after a trial of 12 months (examples: ongoing significant BMD loss, lack of BMD increase, or fracture) OR (b) significant intolerance to oral bisphosphonates; OR iii) cannot take an oral bisphosphonate due to swallowing difficulty, inability to remain upright, or pre‑existing GI condition; OR iv) either (a) severe renal impairment with evaluation for chronic kidney disease mineral and bone disorder (example: CrCl < 35 mL/min) OR (b) patient has had an osteoporotic/fragility fracture.

Dosing: 60 mg subcutaneously once every 6 months.

Postmenopausal osteoporosis (treatment): Approve for 1 year if BOTH A and B are met: A) patient meets ONE of: i) current or past T‑score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius; OR ii) patient has had an osteoporotic/fragility fracture; OR iii) patient has low bone mass (T‑score between -1.0 and -2.5) AND, according to the prescriber, is at high risk for fracture; AND B) patient meets ONE of: i) tried ibandronate IV or zoledronic acid IV; OR ii) tried ≥1 oral bisphosphonate and (a) inadequate efficacy after 12 months OR (b) significant intolerance; OR iii) cannot take oral bisphosphonate for listed reasons; OR iv) severe renal impairment with CKD‑MBD evaluation OR prior osteoporotic/fragility fracture.

Dosing: 60 mg subcutaneously once every 6 months.

Osteoporosis treatment in men: Approve for 1 year if BOTH A and B are met: A) patient meets ONE of: i) current or past T‑score ≤ -2.5 at lumbar spine, femoral neck, total hip, or 33% radius; OR ii) patient has had an osteoporotic/fragility fracture; OR iii) patient has low bone mass and, according to the prescriber, is at high risk for fracture; AND B) patient meets ONE of: i) tried zoledronic acid IV; OR ii) tried ≥1 oral bisphosphonate and (a) inadequate efficacy after 12 months OR (b) significant intolerance; OR iii) cannot take oral bisphosphonate for listed reasons; OR iv) severe renal impairment with CKD‑MBD evaluation OR prior osteoporotic/fragility fracture.

Dosing: 60 mg subcutaneously once every 6 months.

inv-02: Other supported uses

Treatment of bone loss in prostate cancer (supportive): Approve for 1 year if the patient is receiving androgen deprivation therapy (examples: leuprolide formulations, degarelix, relugolix, triptorelin, goserelin).

Dosing: 60 mg subcutaneously once every 6 months.

Increase BMD in patients with breast cancer (supportive): Approve for 1 year if ONE of the following is met: A) patient is postmenopausal AND receiving aromatase inhibitor therapy; OR B) patient is premenopausal AND receiving estrogen deprivation therapy (examples provided in policy).

Dosing: 60 mg subcutaneously once every 6 months.

inv-03: Conditions and limitations (excerpt)

Coverage stance and explicit conditions from this section:

Concurrent Use Restrictions: Denosumab products (Prolia and biosimilars) must NOT be used concurrently with other osteoporosis medications (examples include teriparatide, abaloparatide, oral or IV bisphosphonates, calcitonin, romosozumab); concurrent use with other denosumab products (e.g., Xgeva) is not recommended. Calcium and/or vitamin D supplementation may be used concomitantly.

Referenced examples listed in policy.

Giant Cell Tumor of Bone: Studies of giant cell tumor of bone used dosing of denosumab subcutaneous injection (Xgeva and biosimilars); Xgeva is indicated for unresectable giant cell tumor of bone or when resection would cause severe morbidity — this dosing/indication is distinct from Prolia products for osteoporosis.

See prescribing differences between Xgeva and Prolia.

Not Indicated for Prevention: Denosumab products (Prolia and biosimilars) are not indicated for the prevention of osteoporosis; coverage is not recommended for uses not listed in the Recommended Authorization Criteria.

Criteria will be updated as new data are available.

Requests for denosumab products (Prolia and listed biosimilars) for concurrent use with other denosumab products (for example, Xgeva or its biosimilars) are not recommended. The prescribing information warns that patients receiving one denosumab product should not receive another denosumab product concomitantly, and combining denosumab products is contraindicated.

Similarly, denosumab products should not be prescribed concurrently with other osteoporosis medications (for example, teriparatide, abaloparatide, oral or IV bisphosphonates such as alendronate or zoledronic acid, calcitonin, or romosozumab). Denosumab products are not indicated for use as combination therapy, although calcium and/or vitamin D supplementation may be used together with denosumab.

Concurrent use with other osteoporosis medications or with other denosumab products is listed among the Conditions Not Recommended for Approval. Examples of such medications include teriparatide, abaloparatide, oral bisphosphonates (e.g., alendronate, risedronate), IV bisphosphonates (e.g., zoledronic acid), calcitonin, and romosozumab.

The policy explicitly notes that concurrent administration of different denosumab products (for example, Xgeva and Prolia or biosimilars) is not recommended; this condition was added to the policy as a specified denial trigger and therefore requests meeting this circumstance should not be approved.

Denosumab products (Prolia and biosimilars) are not indicated for osteoporosis prevention. Coverage is not recommended for prevention or for uses that are not listed in the policy's Recommended Authorization Criteria; requests for such uses should be denied.

Use of denosumab products for the prevention of osteoporosis is not indicated and therefore not recommended for coverage. Only the treatment and supportive indications specified in the Recommended Authorization Criteria are appropriate bases for approval.

Product Names, Codes, and Dosing

Named products (brand and biosimilars)NDC | mixed

Product list

Bildyos (denosumab-nxxp), Bosaya (denosumab-kyqq), Conexxence (denosumab-bnht), Enoby (denosumab-qbde), Jubbonti (denosumab-bbdz), Ospomyv (denosumab-dssb), Prolia (denosumab), Stoboclo (denosumab-bmwo)

Referenced products and prescribing informationmixed

Prolia	denosumab subcutaneous injection (originator product) — referenced in prescribing information
Jubbonti	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Stoboclo	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Conexxence	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Bildyos	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Ospomyv	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Enoby	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Bosaya	denosumab subcutaneous injection (biosimilar) — referenced in prescribing information
Xgeva	denosumab subcutaneous injection dosing for giant cell tumor of bone (distinct indication)

Dosing interval

Standard dose and interval60 mg subcutaneously once every 6 months

RouteSubcutaneous injection

Applies toAll FDA‑approved and supported indications in this policy

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of denosumab products (Prolia and biosimilars). Approvals are provided for specified FDA‑approved and supported indications when the request meets the policy's authorization criteria. Biosimilar products follow the same criteria, dosing, and approval duration as the originator product.

Approvals are typically provided for 1 year.
Biosimilars (e.g., Jubbonti, Stoboclo, Conexxence, Bildyos, Bosaya) are evaluated using the same criteria as Prolia.

Documentation Required

Authorization Criteria and Biosimilars

Authorization will only be recommended when the submitted request meets the policy's required clinical criteria for the specific indication (see criteria groups for FDA‑approved indications). Providers must document the clinical rationale showing how the patient meets all applicable criteria for the requested indication and dosing.

Key Definitions and Clinical Thresholds

High risk of fracture

DefinitionHistory of osteoporotic fracture, multiple risk factors for fracture, or failure/intolerance to other available osteoporosis therapies

Examples of risk factorsPrior fragility fracture or low T‑score (per FDA‑approved indication definitions)

Role in authorizationUsed to determine eligibility for treatment indications (postmenopausal, men, cancer‑related bone loss, glucocorticoid‑induced)

Severe renal impairment

Example thresholdCreatinine clearance < 35 mL/min is provided as an example of severe renal impairment

CKD‑MBD evaluationPatients with advanced CKD should be evaluated for chronic kidney disease mineral and bone disorder prior to denosumab to reduce hypocalcemia risk

Clinical Background

Denosumab products (Prolia and biosimilars) are receptor activator of nuclear factor kappa‑B ligand (RANKL) inhibitors indicated to increase bone mass and reduce fracture risk in specific patient populations, including postmenopausal women with osteoporosis, men at high risk for fracture, bone loss associated with aromatase inhibitor or androgen deprivation therapy, and glucocorticoid‑induced osteoporosis. The standard dosing referenced in the policy is 60 mg subcutaneously once every 6 months, and the product labeling includes a Boxed Warning about risk of severe hypocalcemia in patients with advanced chronic kidney disease; evaluation for chronic kidney disease mineral and bone disorder (CKD‑MBD) is recommended where applicable prior to use.

Policy Updates and Material Changes

2024-10-23annual_review

Policy name changed from 'Bone Modifiers - Prolia' to 'Bone Modifiers - Denosumab Products (Prolia)'; wording updated to use 'denosumab products (Prolia, biosimilar)'; criteria combined and phrase 'according to the prescriber' added; requirement added to evaluate for CKD‑MBD to reduce Prolia‑induced hypocalcemia; Jubbonti added as a biosimilar with same criteria as Prolia.

2025-05-14selected_revision

Stoboclo was added to the policy with the same authorization criteria as Prolia; policy language updated to note multiple biosimilars.

2025-06-11